Fruquintinib Sequential BEV+FOLFIRI vs. BEV+FOLFIRI Sequential Fruquintinib in Metastatic Colorectal Cancer

NCT05447715 | Unknown Phase 2

• 1 other identifier: FBIRI
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open, multicenter, randomized controlled phase II study designed to observe the difference of efficacy, adverse events and quality of life between second-line and third-line application of Fruquintinib in patients with metastatic colorectal cancer. The study will evaluate PFS, ORR, OS and safety.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer; Fruquintinib; bevacizumab (BEV); FOLFIRI; second-line treatment; third-line treatment

Outcome Measures

Primary Outcomes (1)

• Sequential treatment of PFS with furoquitinib in second-line (F-C group) versus third-line (C-F group)

  Sequential PFS is defined as: F-C group: time from randomization to disease progression or death after drug C, whichever occurred first. C-F group: time from randomization to disease progression or death after use of F drug, whichever occurred first.

  10 months

Study Arms (2)

Fruquintinib sequential BEV+FOLFIRI

OTHER

Drug: Fruquintinib

BEV+FOLFIRI sequential fruquintinib

OTHER

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquintinib sequential BEV+FOLFIRI vs. BEV+FOLFIRI sequential fruquintinib in the treatment of metastatic colorectal cancer that has failed previous fluorouracil/oxaliplatin therapy

BEV+FOLFIRI sequential fruquintinib; Fruquintinib sequential BEV+FOLFIRI

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Be 18 or older;
• patients with metastatic colorectal adenocarcinoma confirmed by histopathology or cytopathology;
• Failure of first-line oxaliplatin combined with fluorouracil (combined with or without targeted therapy);
• With one or more measurable lesions, the longest diameter determined by spiral CT scan should be at least 10 mm, and the longest diameter determined by conventional CT scan should be at least 20 mm (efficacy evaluation criteria for solid tumors, namely RECIST criteria, version 1.1);
• Eastern Oncology Collaboration group (ECOG) General status score 0 or 1;
• The expected survival time is more than 3 months;
• Hematopoietic function, liver and kidney function should meet the following criteria within 7 days before screening:
• Absolute neutrophil count ≥ 1.5x109 /L; Hemoglobin ≥ 9.0g/dL; Platelet count ≥ 80 x109 /L; Total bilirubin ≤1.5 times normal upper limit (ULN); Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN; Alkaline phosphatase ≤ 3 x ULN; Serum creatinine ≤1.5 x ULN;
• Men, women of reproductive age (postmenopausal women must have been in menopause for at least 12 months to be considered infertile), and their partners voluntarily used contraceptive methods that the investigator considered effective during treatment and for at least six months after the last study drug was taken.

You may not qualify if:

• Subjects who meet any of the following criteria will not be enrolled:
• BRAF V600E mutation confirmed by histological or blood ctDNA gene test;
• Heavy tumor load (such as liver tumor accounting for more than 50% of the liver volume, or a single tumor lesion with a diameter of more than 5 cm, or chest tightness, shortness of breath and other symptoms, lung metastasis that has affected respiratory function);
• First-line treatment with irinotecan;
• The patient has ascites or peritoneal metastasis;
• Uncontrolled pleural effusion;
• There is a risk of bleeding, such as a large surgical operation within one month or a small needle biopsy within two weeks; There was active gastrointestinal bleeding. Severe unhealed wounds; Hereditary bleeding tendency or coagulopathy.
• History of gastrointestinal perforation or abdominal abscess within 6 months prior to enrollment.
• Uncontrolled hypertension (systolic blood pressure \& GT; 150mmHg and/or diastolic pressure \> 100mmHg), clinically significant cardiovascular disease, such as symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), congestive heart failure exceeding the New York heart association (NYHA) class III or IV, stroke, or transient ischemic attack.
• Active clinical infection;
• Symptomatic brain or meningeal metastasis (unless the patient is treated \> At 6 months, imaging results were negative within 4 weeks prior to study entry and tumor-related clinical symptoms were stable at study entry);
• Patients whose seizures require management (e.g. steroids or antiepileptic therapy);
• Undergoing kidney dialysis;
• Have a history of other malignant tumors within 3 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
• Chronic intestinal diseases, infectious intestinal diseases, intestinal obstruction;

Sponsors & Collaborators

• Weijian Guo: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Weijian Guo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinjia Chang

CONTACT

+86-021-64175590; iamchangjinjia@163.com

Weijian Guo, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 7, 2022
• Study Start: August 31, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)